Lung CancerPhase 3NCT00139971
Phase III Study of Gemcitabine Compared With UFT in Patients With Completely Resected Pathological Stage IB-IIIa Non Small Cell Lung Cancer
A Phase 3 study testing gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6 and UFT 250mg/m2, daily for 1 year in people with Lung Cancer, run by West Japan Thoracic Oncology Group at 1 site in Japan.
Trial summary
To estimate the efficacy of Gemcitabine monotherapy compared to UFT as the post operative adjuvant chemotherapy for completely resected non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6 and UFT 250mg/m2, daily for 1 year
- How many people
- 600 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2001to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- completely resected non small cell lung cancer
- no prior anti cancer treatment for thoracic malignancy exept for this operation
- pathological stage IB, II, and stage IIIA with only one station of n2 disease
- PS 0-1
- age 20-75
- adequate organ function for chemotherapy
- written informed consent
Who cannot join
- small cell lung cancer or low grade malignancy of lung cancer
- incomplete resection
- apparent interstitial pneumonitis at chest rentogenogram
- inadequate condition for chemotherapy
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Osaka City General Hospital
Osaka, Osaka, 531-0021
Hirohito Tada, MD, +81-6-6929-1221, htada@attglobal.net
Hirohito Tada, MD
About this study
To estimate the efficacy of Gemcitabine monotherapy compared to UFT as the post operative adjuvant chemotherapy for completely resected non-small cell lung cancer.
- Conditions
- Lung Cancer
- Being tested
- gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6, UFT 250mg/m2, daily for 1 year
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6Drug
UFT 250mg/m2, daily for 1 yearDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
5 year survival rate
Secondary outcomes (1)
Disease free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- West Japan Thoracic Oncology Group
- Sponsor type
- University, hospital or other
- Investigators
- Hirohito Tada, MD, Principal investigator, West Japan Thoracic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139971
- Sponsor's protocol ID
- WJTOG0101
- Status last verified
- Aug 2005
- First submitted
- 30 Aug 2005
- Last updated
- 6 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Gemcitabine Compared With UFT in Patients With Completely Resected Pathological Stage IB-IIIa Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00139971
- Acronym / sponsor ID
- WJTOG0101
- Conditions
- Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants
- Lead sponsor
- West Japan Thoracic Oncology GroupUniversity, hospital or other
- Study start
- Dec 2001
- First posted
- 31 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To estimate the efficacy of Gemcitabine monotherapy compared to UFT as the post operative adjuvant chemotherapy for completely resected non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- completely resected non small cell lung cancer
- no prior anti cancer treatment for thoracic malignancy exept for this operation
- pathological stage IB, II, and stage IIIA with only one station of n2 disease
- PS 0-1
- age 20-75
Key exclusion criteria (4 listed)
- small cell lung cancer or low grade malignancy of lung cancer
- incomplete resection
- apparent interstitial pneumonitis at chest rentogenogram
- inadequate condition for chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6 | Drug | – |
| UFT 250mg/m2, daily for 1 year | Drug | – |
Primary outcome
5 year survival rate
1 secondary outcome
Disease free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2006.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hirohito Tada, MD principal investigator
West Japan Thoracic Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6 and UFT 250mg/m2, daily for 1 year in people with Lung Cancer, run by West Japan Thoracic Oncology Group at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hirohito Tada, MD (+81-6-6929-1221, htada@attglobal.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 year survival rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2006.